OICR launches Phase III Active Surveillance Magnetic Resonance Imaging Study Trial

Dr. Nicole Onetto, Deputy Director and Chief Scientific Officer of the Ontario Institute for Cancer Research (OICR), today announced the launch of an innovative Phase III clinical trial that aims to determine whether multi-parametric magnetic resonance imaging (MRI) coupled with transrectal ultrasound (TRUS) guided biopsy (called fusion technology) can accurately identify men with prostate cancer who are at risk of developing aggressive disease.

The study, called the Active Surveillance Magnetic Resonance Imaging Study Trial (ASIST), recently enrolled its first 10 patients. Researchers are aiming to enroll 275 men over the next three years who have recently been diagnosed with prostate cancer, with primary analysis planned one year after study recruitment is complete.

"The goal of this study is to provide new and useful information to help decide which patients would benefit from aggressive treatment and which would benefit from active surveillance," said Dr. Onetto. "This would improve the cure rate in those who have high-risk disease while reducing the number of patients now choosing radical treatment when it is not warranted. This could improve quality of life for hundreds of thousands of men worldwide."

Many prostate cancers are not aggressive and patients can benefit from active surveillance, a strategy where a patient's tumour is monitored over time to establish whether it is harmful or not. Currently many men choose to have surgery, chemotherapy and/or radiation instead of active surveillance because it is not possible to reliably assess the prognosis of low-risk tumours. Because side effects of these treatments are often serious and long lasting, determining with certainty whether they are necessary provides a huge long-term benefit to patients.

The Study is Chaired by Dr. Laurence Klotz, Professor of Surgery at the University of Toronto and an Associate Scientist at Sunnybrook Health Sciences Centre, and Co-chaired by Dr. Masoom Haider, Head of Abdominal MRI at the Joint Department of Medical Imaging at Princess Margaret Hospital and Mount Sinai Hospital and Dr. Andrew Loblaw, Scientist and Radiation Oncologist at the Odette Cancer Centre at Sunnybrook Health Sciences Centre.

"A positive trial could change clinical practice and result in the widespread adoption of MRI targeted biopsies, enhanced with the TRUS fusion technology, to help prostate cancer patients worldwide," said Dr. Klotz. "The MRI fusion technology could identify those patients needing immediate therapy. This would reduce cancer mortality for patients with more aggressive disease and provide significant reassurance and increase the appeal of active surveillance for subjects with less aggressive forms."

"The current biopsy process is blind, involving 12 or more random needle samples," said Dr. Haider. "We need a 'manogram' to help detect and direct a needle to any potential hidden aggressive cancer. If this trial is positive, MRI will save lives and reduce morbidity by enabling better detection of occult aggressive disease with far fewer biopsies."

This study was made possible as a result of technology developed with OICR funding by Dr. Aaron Fenster, co-director of OICR's Smarter Imaging Program and Imaging Translation Platform and Director, Imaging Research Laboratories, Robarts Research Institute and now manufactured by Eigen. "MRI fusion technology is the product of years of work by Ontario researchers," said Dr. Fenster. "The ASIST study presents an exciting opportunity to use this technology right here in Ontario to help improve treatment options for patients worldwide."

Active surveillance is increasingly recognized as being crucially important to reducing the overtreatment of non-aggressive disease while retaining the option of definitive therapy for those patients reclassified over time as higher risk. There are approximately 150,000 new patients diagnosed in North America each year who are candidates for active surveillance and this number is expected to increase dramatically over the next two decades.

OICR is providing $2.8 million in funding over five years for the study. The study is a joint effort by three Ontario clinical centres: the London Health Sciences Centre in London, and Sunnybrook Health Sciences Centre and the University Health Network in Toronto. The ASIST study is being coordinated and managed by the Canadian Urology Research Consortium. The Ontario Clinical Oncology Group in Hamilton, led by Dr. Mark Levine, Department of Oncology, McMaster University will provide clinical data management and biostatistics support.